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Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women

Primary Purpose

Urinary Incontinence

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Constructivist interactive workshop on urinary incontinence

Evidence-based self-management tool

General health lecture

About this trial

This is an interventional health services research trial for Urinary Incontinence focused on measuring urinary incontinence, self-management, cost, self-efficacy, continence promotion

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female
60 years or older
Urinary incontinence twice weekly
Women who have not sought medical advice for incontinence symptoms in the last 2 years.
Fluent in English

Exclusion Criteria:

Women who have received treatment for their urinary incontinence within the past two years from a health care provider with expertise in urinary incontinence management (i.e. nurse practitioners/physicians/surgeons who have a clinical practice that focuses on treating urinary incontinence).
Women started on medications for urinary incontinence (i.e. antimuscarinic medication) within the 6 months prior to enrolment.
Women with a history of a neurological condition (e.g. Multiple Sclerosis and spinal cord injury) because they require further investigation. Women identified to have these historical findings will be advised to speak to their physician immediately about their incontinence and the possible need for investigation.
Women who do not consent to participate.

Sites / Locations

Brunel University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Arm Label

Self-management

General Health Lecture

Combined workshop and self-management

Workshop

Arm Description

Outcomes

Primary Outcome Measures

Incontinence frequency

Reductions in incontinence frequency as indicated on a 72-hour voiding diary at 3-months post-intervention compared to baseline.

Secondary Outcome Measures

Cost of pad use

Reductions in the cost of pad use per day at 3-months post intervention compared to baseline.

Self-efficacy for managing incontinence

An increase of 5 points or more on the Geriatric Self-Efficacy index for urinary incontinence at 3-months post-intervention compared to baseline.

Full Information

NCT ID

NCT01239836

First Posted

November 10, 2010

Last Updated

May 14, 2013

Sponsor

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Collaborators

Brunel University, Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT01239836

Brief Title

Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women

Official Title

Self-management, Constructivism or Both as Knowledge Transfer Strategies for Reducing the Cost and Impact of Urinary Incontinence Among Community-dwelling Senior Women in the United Kingdom

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Collaborators

Brunel University, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Urinary incontinence is a common and bothersome condition that remains frequently untreated among senior women. The aim of this trial is to compare the effectiveness of two community-based continence promotion interventions aimed at improving rates of self-care and/or professional health-care seeking in older women with urinary incontinence. The main hypothesis posits that participation in a constructivist interactive workshop combined with use of an evidence-based self-management tool will yield rates of improvement in incontinence frequency and reduce the cost of pad use by 20% compared to either intervention alone, which individually are expected to yield minimal effect sizes of at least 0.3 compared to a sham intervention.

Detailed Description

The research design is a 2x2 factorial open-label cluster randomised controlled trial. The cluster (unit of randomization) is at the level of each local community senior's group, from whence participants will be recruited. Incontinent community-dwelling older women aged 60 years and older who have not sought care for their urinary symptoms in the last two years, but who experience incontinence at least twice weekly will be recruited through local community organizations. Eligible participants from each local community centre will be randomly assigned as a group to one of four interventions. The first intervention is participation in an interactive constructivist continence workshop. The second intervention involves receipt of an evidence-based self-management tool for incontinence. The third group will receive both interventions. The fourth group will act as the control group: they will simply be asked about their urinary symptoms and given a general talk on women's health. At the end of the study, the control group will be offered the self-management tool.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence

Keywords

urinary incontinence, self-management, cost, self-efficacy, continence promotion

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

259 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Self-management

Arm Type

Experimental

Arm Title

General Health Lecture

Arm Type

Sham Comparator

Arm Title

Combined workshop and self-management

Arm Type

Experimental

Arm Title

Workshop

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Constructivist interactive workshop on urinary incontinence

Intervention Description

A one hour interactive group workshop aimed at contradicting commonly held beliefs and maladaptive practices about incontinence. The interactive continence workshop was designed to create cognitive dissonance and challenge these beliefs and practices, as well as to promote more effective therapeutic strategies for correcting urine leakage.

Intervention Type

Behavioral

Intervention Name(s)

Evidence-based self-management tool

Intervention Description

Participants will receive a customized evidence-based risk factor modification self-management tool targeting up to 6 risk factors and associated therapeutic strategies. The six risk factors are pelvic floor muscle weakness, consumption of caffeinated drinks, obesity, constipation, vision loss and smoking.

Intervention Type

Behavioral

Intervention Name(s)

General health lecture

Intervention Description

Participants will attend a lecture on general women's health issues that does not address urinary incontinence.

Primary Outcome Measure Information:

Title

Incontinence frequency

Description

Reductions in incontinence frequency as indicated on a 72-hour voiding diary at 3-months post-intervention compared to baseline.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Cost of pad use

Description

Reductions in the cost of pad use per day at 3-months post intervention compared to baseline.

Time Frame

3 months

Title

Self-efficacy for managing incontinence

Description

An increase of 5 points or more on the Geriatric Self-Efficacy index for urinary incontinence at 3-months post-intervention compared to baseline.

Time Frame

3-months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female 60 years or older Urinary incontinence twice weekly Women who have not sought medical advice for incontinence symptoms in the last 2 years. Fluent in English Exclusion Criteria: Women who have received treatment for their urinary incontinence within the past two years from a health care provider with expertise in urinary incontinence management (i.e. nurse practitioners/physicians/surgeons who have a clinical practice that focuses on treating urinary incontinence). Women started on medications for urinary incontinence (i.e. antimuscarinic medication) within the 6 months prior to enrolment. Women with a history of a neurological condition (e.g. Multiple Sclerosis and spinal cord injury) because they require further investigation. Women identified to have these historical findings will be advised to speak to their physician immediately about their incontinence and the possible need for investigation. Women who do not consent to participate.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cara Tannenbaum, MD

Organizational Affiliation

Centre de recherche de l'Institut universitaire de gériatrie de Montréal

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eleanor van den Heuvel, PhD

Organizational Affiliation

Brunel University

Official's Role

Study Director

Facility Information:

Facility Name

Brunel University

City

Uxbridge

State/Province

Middlesex

ZIP/Postal Code

UB8 3PH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

19693950

Citation

Tannenbaum C, Drali R, Holroyd-Leduc J, Richard L. Lessons learned: impact of a continence promotion activity for older community-dwelling women. Neurourol Urodyn. 2010 Apr;29(4):540-4. doi: 10.1002/nau.20800.

Results Reference

background

PubMed Identifier

24334159

Citation

Tannenbaum C, Agnew R, Benedetti A, Thomas D, van den Heuvel E. Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial. BMJ Open. 2013 Dec 10;3(12):e004135. doi: 10.1136/bmjopen-2013-004135.

Results Reference

derived

Learn more about this trial

Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women

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